BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 874221 · Received June 29, 2007

    Report

    Report Number
    1028232-2007-00223
    Event Type
    Injury
    Date Received
    June 29, 2007
    Date of Event
    May 17, 2007
    Report Date
    May 30, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER MDRF "PT INCISION OPENED, WAS DRAINING, DOCTOR DECIDED TO EXTRACT UNIT". LEXOS DR, MDR 1028232-07-0222. LINOX SD 65/16, MDR 1028232-07-0224.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD DTB BIOTRONIK GMBH AND CO. 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization